Founder, Ascenda Medical Marketing | Expertise in Advancing Medical Technology
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Hello, Med Device Community. I am consulting with an early commercialization company that has a device used in emergent situations, so use is not planned.
Our challenge is trying to collect evaluation forms for prospective accounts with the intention of providing data to clinical and economic stakeholders on usage and experience.
Does anyone have any creative ways you’ve employed to ensure:
Right now we are just using a hand written form that is photographed and emailed in, but compliance remains low. I’d love to go to an electronic form, but would love to hear of someone’s experience with this given HIPAA and contamination concerns. Thank you!
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Hi Amy. I use jotform.com as a resource for online forms. They are simple, precise, with lots of options and tools with central collection defined by the user. They have HIPPA compliant options as well.
I’m a little confused on what you’re trying to evaluate when the use is not planned. I’ve managed some fairly complex product evaluations and I’d be glad to be your sounding board and advisor.
Let me know how I can help.
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Sometimes positive or altruistic motivation is enough to get forms filled out. (This would be true whether you were using paper, or a secured app, or a web-based secure app.)
And, sometimes, it is not.
As a consultant, I would, too often, have a problem with a customer losing track of a cost of a project, or the progress of it, resulting in a huge surprise on their end. You can only *imagine* the phone calls that got over the years, but, even worse, the level of dissatisfaction whose accumulation had preceded those calls!
So, some years ago, I started maintaining cost sheets in the cloud, with work descriptions beside them. I also maintained a design journal in the cloud, with screen shots of design progress. I sent them links to the data, and re-sent the links every so often.
Now, do I think my clients spent time every day — or *ever* — looking over these sheets? No. But the concerned phone calls stopped.
This is not an example of how to get your forms filled out, but rather the kind of thinking that will help you to do so. I had to spend some time trying to divine how get the results I wanted: (1.) No surprised panic calls, and (2.) clients with current work continuing for many months, and even years, and how to generate the motivations to make it happen. I honestly do not think that my clients tap that link every day to check their costs, but, like a FedEx tracking link, they can.
Forms, like surveys, may suffer from, or benefit from, design. I have had surveys that I terminated early simply because they were so in-artfully done.
The question is, what will make *anyone*, after filling out one portion, to proceed to the next?
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Thanks to both of you for your input. Chuck - by non-planned case, I am differentiating between a scheduled surgical procedure, where the rep can be sure to be available. For this device they may have 5 patients in one week and no patients for another 10 days. It is hard to plant a rep out at an account to support use for all 10 desired eval cases when timing is so unpredictable. Rick - your proposal is interesting. I'm not sure our customer base would be interested in that level of data from their end, but we do provide an evaluation summary highlighting how/when the device was applied and user input. We feel that helps other stakeholders in the practice see the benefit, ultimately supporting the sales process. Thanks again!
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I'll note a few recommendations, and then describe a more involved solution that worked for us in the past at the bottom:
I agree with Chuck that you should be able to find and use a form system that is already HIPAA compliant. Here's an interesting one I came across for a different context (intake forms), that presumably takes care of contamination concerns as well: https://formdr.com/.
If you're doing this yourself, though, a good way to increase compliance is to *decrease friction* (in the process of submitting the form).
For example, in the case of your current process, I would look at what kind of device is taking the pictures of the paper forms and how they are then emailed out. Can this be simplified? E.g. saving images to a computer and emailing them 1-by-1 sounds a little cumbersome. Is there an opportunity to have saved images sync directly with a secured/compliant server? (By the way, there should be a clear incentive for doing this work if it isn't always done by the rep.)
I would also look at the form itself. Is there any information being captured that could be gathered from a complimentary source, or after-the-fact, in order to shorten the form at all? Are the questions designed in a way for effortless response? E.g. are there opportunities to provide a Likert scale or checkboxes, etc., instead of free-form text input?
I would also try to find friendly staff at locations with lower compliance and simply have them walk you through their process. You might be surprised with what you find, and simple fixes may become obvious.
We once had a situation where we needed to collect protected information like this, and had very little control over the environment. I'm not sure your project has the resources to go this far, but we decided to develop a research toolkit in the form of an app that was distributed on tablets.
Similar to the points above, we took extra care to design the form to be not only easy, but kind of fun to fill out. We boiled the information being collected via the form down into the smallest possible data set, and we made the interface visual and simple to click through. With a WiFi connection, all of the data was seamlessly stored to a secured server. We also included visual animated instructions for device usage, feedback and contact channels, a feature for taking pictures to add to the record, and access to our online forms and resources. (It was so feature rich and useful that the concept was spun off into https://www.usable.guide/.)
Please note, though, that you don't need a bespoke app to do most of this. An online form/toolkit would suffice so long as it's also designed to work well on mobile devices.
In summary, I would start by seeing if you can work with your locations to simplify the current process. They are best positioned to shed light on why compliance is lower!
Then, I would definitely look at going digital--but again, ensure that this is an actual improvement in the field before investing. ;-)
Hope this helps! Please feel free to contact me if you'd like to discuss further.
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Is the product something that reduces surgical time, mitigates a risk, or has some other 'tangible' benefit at the practice management level? Is it essential to collect data at the time of the procedure, or is there something, perhaps in the billing records, that could be of value. I might be skirting the question, but if you are looking for data from existing accounts that would be compelling to prospective accounts, then you don't necessarily need 'everyone' to participate.
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